FDA approves Bristol-Myers Squibb’s Orencia for active psoriatic arthritis
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Orencia for the treatment of adult patients with active psoriatic arthritis (PsA).
PsA is a chronic, inflammatory disease in which the immune system attacks healthy joints and skin.
The disease affects a person's skin and musculoskeletal system, causing joint pain, stiffness and reduced range of motion.
The treatment is approved and available in intravenous (IV) and subcutaneous (SC) injection formulations.
Bristol-Myers Squibb Orencia development lead and vice-president Brian Gavin said: “This approval underscores the efficacy of Orencia in adult patients with active PsA, who have been in need of new treatments.
“Helping to advance clinical understanding of autoimmune conditions is a key focus of our immunoscience research, and we’re proud to introduce Orencia, a selective T-cell co-stimulation modulator, as an additional treatment option for PsA.”
The co-stimulation blockade of the treatment inhibits T-cell activation and the resulting series of events that lead to inflammation. T-cell activation is involved in the pathogenesis of PsA.
The FDA approval was based on results from two randomised, double-blind, placebo-controlled trials, PsA-I and PsA-II.
The studies demonstrated that Orencia can improve or reduce disease activity in both TNF-naive and exposed patients with high-disease activity, a high level of tender and swollen joints, and a disease duration of more than seven years.
The safety profile of the treatment was comparable between studies PsA-I and PsA-II and consistent with the safety profile in RA.
Orencia is not recommended to be used concomitantly with TNF antagonists and other biologic Rheumatoid Arthritis (RA) therapy, such as anakinra.